Prostate Cancer Patients Undergoing External Radiation and Seed ImplantationHigh Risk Localised Prostate CarcinomaLocally Advanced Prostate CancerUnfavourable Intermediate Risk Prostate Cancer
Investigational drug(s) / intervention(s)
Addition of focal boost and hypofractionation
Addition of focal boost and hypofractionation: Addition of focal boost to primary radiotherapy for prostate cancer in 12 or 20 fractions
Study summary
Every year, about 700 Danish men get radiotherapy for prostate cancer with a high-risk of later progression. The risk of relapse is about 40 % after 5 - 8 years, so we need better treatment for these patients in Denmark and globally. The aim is to reduce later cancer spreading, need of hormone treatments and prostate cancer death.
DAPROCA 10 tests two possible improvements:
If a higher dose (boost) to intra-prostatic tumor lesions improves cure rates. If the radiotherapy can be given with 12 treatment fractions instead of 20 without increased side-effects.
In this randomised trial half the participants get a boost and the other half don't. Half the patients get 12 treatments, the other half 20.
To answer these questions we must include1016 participants. The trial is feasible because the technological advances in imaging and radiotherapy enables us to define the tumors in the prostate and to deliver the boost to the tumors with high precision, without increased dose to the surrounding organs.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with biopsy verified PCa with no distant metastases with either
* Intermediate- or high-risk PCa, defined as at least one of the following risk criteria:
* Clinical stage cT2c-T3b (UICC TNM 8th edition)
* Imaging stage, T3a or T3b
* ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
* Regional lymph node metastases N1
* Age \> 18
* WHO score 0-1
* Intraprostatic lesion visible on MRI
* Suitable for focal boost
* Ability to give written informed consent and willingness to return for follow-up
Exclusion Criteria:
* WHO performance status ≥ 2
* If, for any patient related reason, an MRI cannot be performed
* T4
* International prostate symptom score (IPSS) ≧ 20
* If fiducial markers cannot be inserted
* TURP within 3 months from start of treatment
* Previous pelvic irradiation
* If the patient is judged by the physician to be unable to adhere to trial activities
* History of chronic inflammatory bowel disease (CIBD)
Primary outcome measure(s)
Freedom from distant metastasis — Time from enrollment to confirmation of occurence of radigraphic distant metastases. The patients are followed for 123 months after start of radiotherapy. Metastses is verified by PSMA scan which is recommended:
* If a recurrence is suspected biochemically according to biochemical relaps accordingly to the Phoenix criteria
* If a recurrence is suspected clinically, e.g: Bone pain, anemia, urinary symptoms
* If recurrence is suspected by radiographic test Biopsy is also accepted and MRI, CT, bone scintigraphy, NAF-PET, ultrasound or clinical examination may also be accepted with further confirmation, e.g. biopsy or laboratory tests.
If the event "distant metastasis" is based on tests without biopsy or PSMA positivity the event shall be confirmed at a multi-disciplinary tumor board.
Trial sites (3)
Facility
City
Region
Status
Aurhus University Hospital
Aarhus
Denmark
Not Yet Recruiting
Rigshospitalet
Copenhagen
Denmark
Recruiting
Sygehus Lillebaelt
Vejle
Denmark
Not Yet Recruiting
More Copenhagen University Hospital, Rigshospitalet trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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